Clinical Feasibility of a New Voice Prosthesis

Atos Medical

Status: Completed

Conditions: Laryngectomy

Treatments: Device: New Voice Prosthesis

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05079386

N21VEG

Details and patient eligibility

About

The objective of this clinical investigation is to evaluate the short-term clinical feasibility of a new voice prosthesis and explore its acceptability, limitations and advantages. As a result of the evaluations, design changes may be implemented and evaluated until the optimal design has been determined, or until it is decided not to pursue further development of the device. Main outcome will be the patient's acceptance of the voice prosthesis, secondary outcomes are stickiness of the valve mechanism and speech.

Enrollment: 17 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Laryngectomized patients using either the Provox Vega 22.5 or the Provox ActiValve Light voice prosthesis, with a length of 4, 6, 8, or 10 mm
• 18 years and older

Exclusion criteria

• Current tracheoesophageal puncture problems such as enlarged puncture or infection
• Active recurrent or metastatic disease (medical deterioration)
• The use of ActiValve Strong/XtraStrong or XtraSeal
• Unable to understand the Patient Information and/or unable to give Informed Consent
• The previous 2 VPs had a device lifetime > 12 months
• History of oral resections negatively affecting speech

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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17 participants in 1 patient group

New Voice Prosthesis

Experimental group

Description:

Patients will use the New Voice Prosthesis for two weeks to investigate short term feasibility and explore limitations and advantages. If the patient wishes to leave the New Voice Prosthesis in situ, this will be allowed under the condition that the subject agrees to remain in the study and report (adverse) events on an ongoing basis, until the device is removed after a maximum of 12 months.

Treatment:

Device: New Voice Prosthesis